PK study of MR prototype coated tablet formulations of GSK2982772
Research type
Research Study
Full title
A two part, non-randomised, open label study designed to assess the pharmacokinetic profile of modified release prototype coated tablet formulations of GSK2982772 relative to an immediate release reference tablet formulation at a fixed strength (Part A) and the pharmacokinetic profile of alternative tablet strengths of the selected modified release prototype coated tablet formulation (Part B, optional) in healthy participants.
IRAS ID
249087
Contact name
Teresa Fuller
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-002370-48
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
The sponsor GlaxoSmithKline Research & Development Limited (also known as GSK) are developing a new formulation (recipe) of the test medicine GSK2982772, for the potential treatment of diseases caused by inflammation such as inflammatory bowel disease (IBD), plaque psoriasis (PsO) and rheumatoid arthritis (RA).
The study will try to identify a new formulation of the test medicine which allows for more convenient once daily dosing for patients.
The study will consist of 2 parts. Part A is an up to 6 period fixed sequence study in 16 healthy male and female volunteers, designed to evaluate up to 4 modified release prototype coated tablet formulations following single 240 mg doses in the fasted state. This part may also investigate the effect of food on a selected formulation, and there is also the option to cancel Periods 5 and 6 if a favourable formulation is determined in Periods 1 or 2.
Part B is an up to 6 period fixed sequence study designed to evaluate up to 4 different modified release formulations selected from Part A at different tablet strengths or as multiple dose units on a single occasion in up to 16 healthy male and female volunteers. Alternatively, if an optimal formulation has not been identified in Part A, Part B may be used to test different formulations. The doses may be given in the fed or fasted state or up to 60 minutes before breakfast. There is also the option to cancel Periods 5 and 6.
REC name
Wales REC 2
REC reference
18/WA/0293
Date of REC Opinion
13 Sep 2018
REC opinion
Favourable Opinion